GlaxoSmithKline and AstraZeneca are considering forming a joint laboratory to help the U.K. government stretch and expand its supplies for COVID-19 diagnostic tests, according to a report from Bloomberg.

Even though diagnostics are not their core efforts, the plan is for the two Big Pharmas to test a range of different reagents, chemical mixtures and other materials for new ways to help detect the spreading novel coronavirus. Successes would be provided to other manufacturers or the U.K.’s National Health Service.

An AstraZeneca spokesperson told Bloomberg the company has contacted the government about using “in-house scientific capabilities to increase the effectiveness of the national testing effort” but did not provide specifics. Meanwhile, GSK said it has provided lab equipment and scientific advice, according to the report.

Click here to read more via FierceBiotech

The NIH is deeply concerned for the health and safety of people involved in NIH research, and about the effects on the biomedical enterprise in the areas affected by the HHS declared public health emergency for COVID-19. Due to the potential exceptional impact, we want to assure our recipient community that NIH will be doing our part to help you continue your research.

This is a rapidly evolving situation and we will provide updated guidance and information as it becomes available.

See page update history.

Guidance

Proposal Submission & Award Management

• UPDATE: NIH Late Application Policy Due to Public Health Emergency for United States for 2019 Novel Coronavirus (COVID-19) – NOT-OD-20-091
• General Frequently Asked Questions (FAQs) – Proposal Submission and Award Management Related to COVID-19 – NOT-OD-20-083
• Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19 – NOT-OD-20-086
• Contracts must be handled on a case by case basis. Details regarding any contract must be directed to the cognizant Contracting Officer. Salary changes must be handled by the contracting officer.

Human Subjects & Clinical Trials

• Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19 – NOT-OD-20-087
• FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic 

Animal Welfare

• COVID-19 Pandemic Contingency Planning for Animal Care and Use Programs
• OLAW Webinar: Pandemic Contingency Planning and Its Impact on Animal Care  – March 19, 2020
• Flexibilities for Assured Institutions for Activities of Institutional Animal Care and Use Committees (IACUCs) Due to COVID-19 – NOT-OD-20-088

Peer Review

• Based on NIH Guidance on Travel and Meetings , in-person NIH peer review meetings are being held in alternate formats. Scientific review officers will be in contact with peer reviewers about these changes.

FAQs – FAQs last updated on March 30, 2020 (history).

• NIH FAQs: COVID-19 Flexibilities for Applicants and Recipients

Click here to read more via grants.nih.gov

• CDMO agreement for NanoFlu to support pathway to licensure
• Expanded collaboration now includes NanoFlu and COVID-19 vaccine candidate

GAITHERSBURG, Md., March 31, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced an agreement with Novavax, Inc. (NASDAQ:NVAX) whereby Emergent will provide molecule-to-market contract development and manufacturing (CDMO) services to produce Novavax’s NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant. Novavax recently announced that NanoFlu met all primary objectives in its Phase 3 clinical trial evaluating immunogenicity and safety in adults aged 65 and older.

“Emergent is pleased to expand our collaboration with Novavax to include large-scale production of NanoFlu, their novel influenza vaccine,” said Syed T. Husain, SVP and CDMO business unit head at Emergent BioSolutions. “Our flexible and integrated CDMO offerings allow us to work with expedited timelines, execute on simultaneous engagements, and serve varying needs and approaches of customers like Novavax. As a trusted partner, we are committed to supporting Novavax’s goals to advance their influenza program while maintaining the option to allocate capacity for a potential scaled-up COVID-19 program.”

Under the terms of the agreement, Emergent will provide drug substance manufacturing services, including technology transfer and process validation and performance qualification to pave the way for commercial manufacturing. This work will be conducted at Emergent’s Baltimore Bayview location, which is designated by the U.S. Department of Health and Human Services (HHS) as a Center for Innovation in Advanced Development and Manufacturing (CIADM), and where the COVID-19 experimental vaccine candidate of Novavax is also being produced. The collaboration allows for flexibility to deploy capacity towards an expanded COVID-19 program.

“Our confidence in partnering with Emergent comes from their reputation for high quality production and ability to scale-up manufacturing,” said Stanley C. Erck, president and chief executive officer of Novavax. “We believe Emergent’s manufacturing capabilities will allow us to capitalize on NanoFlu as an innovative, improved alternative to traditional egg-based flu vaccines.”

Emergent’s Bayview facility has unique capabilities across four independent suites to produce at clinical scale to get candidates rapidly into the clinic, while at the same time scaling up to enable large-scale manufacturing to up to 4000L to prepare for production of commercial volumes to meet customer demand. Additionally, as a CIADM, it has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis, based upon the platform technology being used.

About Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

About NanoFlu™ and Matrix-M™
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. The qNIV vaccine antigens were derived from A/Brisbane 02/2018 H1N1, A/Kansas 14/2017 H3N2, B/Maryland 15/2016 and B/Phuket 3073/2013. NanoFlu contains Novavax’s patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes.

About Novavax
Novavax, Inc. (Nasdaq: NVAX), is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial. ResVax™, its RSV vaccine for infants via maternal immunization, is the only vaccine to demonstrate efficacy in a Phase 3 clinical trial. Novavax recently initiated development of a vaccine program against COVID-19. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our ability to produce the influenza vaccine candidate at the prescribed scale and timeline and pave its potential pathway to licensure, as well as deploy capacity toward an expanded COVID-19 program, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the success of the planned development programs; the timing of and ability to obtain and maintain regulatory approvals for the product candidates; and our commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

Investor Contact:
Robert G. Burrows
Vice President, Investor Relations
240-631-3280
BurrowsR@ebsi.com

Media Contact:
Lynn Kieffer
Vice President, Corporate Communications
240-631-3391
KiefferL@ebsi.com

Endless social media scrolls, 24/7 news channels, newspapers, and radio waves are inundating the public with scary COVID-19 statistics, harrowing tales of medical workers on the front lines of the coronavirus battle, a roller coaster ride stock market and images of empty grocery store shelves and panicked shoppers.

Yes, there is a lot of bad news out there. But there’s also a lot of good.

There’s a national commitment to social distancing and sacrifice to protect the most vulnerable members of society. There are tiny acts of everyday kindness in neighborhoods that go unreported. There are virtual happy hours happening on Zoom and Facetime across the globe. There are family get-togethers done via Skype. First, in family history, virtual birthday parties for kids, parents, and grandparents are happening every day.

Most importantly, there are hundreds of thousands of healthcare workers who continue to go to work every day, putting themselves and their families at a higher risk of contagion, to help treat patients, save lives and fight this pandemic. These medical superheroes represent countless acts of good each and every day across the nation, and the world.

The thing about humans is that when times are the toughest, our fundamental humanity becomes the clearest. In many ways, the kindness and generosity and togetherness we’re all experiencing in some way is reminiscent of the terrifying and confusing days and months after 9/11. The U.S. got sucker punched and knocked down, but we collectively dusted ourselves off and immediately started looking for ways to help our neighbors despite the pain and fear we felt.

Unfortunately, good news doesn’t always get ratings or sell newspapers.

So at BioBuzz, we’re going to fill that good news gap by reporting on some of the amazing and selfless work that’s happening in the healthcare and life science community of the BioHealth Capital Region (BHCR).

Here is the BHCR COVID-19 Good News Roundup for March:

Click here to read more via BioBuzz

Prominent research universities and government agencies are keeping the public abreast of the scope of the coronavirus pandemic as well as the reported outcomes of identified cases.

Major media outlets are doing their best to share information in real-time, but often portray spiking case numbers in hotspots like New York City as the accelerating spread of COVID-19. The reality, in many states across the U.S., is that COVID-19 has already infected large swaths of the population, so the coronavirus is not necessarily “spiking” but rather being revealed through better diagnostics and wider access to COVID-19 testing.

Understanding the difference between media reports of sudden spread and spikes versus reporting on stronger testing and therefore the identification of more cases is critical to flattening the curve.

When communities think in terms of spikes and sudden conflagrations of COVID-19 they might think self-distancing isn’t needed if the community where they reside only has a handful of confirmed cases. If communities approach COVID-19 already assuming it is in their community in larger numbers that haven’t yet been identified through diagnostics and testing, they are more likely to stay home, self distance and contribute to flattening the curve.

This is why accurate diagnostics are so critical to stemming COVID-19.

Strong, widely available and easily accessible testing not only gives scientists the data they need to develop vaccines and potential therapies, but it also avoids the perception that COVID-19 isn’t already present in communities in higher numbers than have been confirmed.

If testing is pervasive and strong at the start of an outbreak, our ability to flatten the curve via new scientific discoveries and modified behaviors increases dramatically.

This is why the diagnostics work being done by these 7 BioHealth Capital Region (BHCR) organizations is so important and should be lauded in this time of uncertainty and crisis.

Click here to read more via BioBuzz.

Bloomberg Philanthropies and the state of Maryland will spend $4 million to back a Johns Hopkins University study into whether the blood of recovered COVID-19 patients can be used to treat patients suffering from the disease.

The effort will also include researchers from nearly two dozen institutions, including the Mayo Clinic, Stanford University Medical Center and the Albert Einstein College of Medicine. Arturo Casadevall, a professor at the Johns Hopkins University Bloomberg School of Public Health and the Johns Hopkins School of Medicine, will lead the study.

“Johns Hopkins is committed to marshaling our clinical and research expertise to stem the tide of this devastating pandemic worldwide,” Ronald J. Daniels, the university’s president, said in a statement. “Dr. Casadevall, like so many other Hopkins researchers, is joining with partners across the globe in a race against the clock, and his work embodies to the fullest our university’s mission to serve humanity through discovery.”

Click here to read more via The Daily Record

“I said I think this will make more lungs more available than anything [else] we could do. And I said I’d like to build a lung hospital,” recalls Keshavjee, who says he and Rothblatt walked onto the office’s balcony, where she pointed to the two-story building across the street. “She said, ‘How about we do that over there?’ ”

A few months later, in the summer of 2013, renovations on the building began, transforming the nondescript former home of private medical and dental offices into a state-of-the-art facility dedicated to EVLP. Keshavjee’s Toronto team remains involved as consultants to Lung Bioengineering, available around the clock for questions during procedures; many of Lung Bioengineering’s staff traveled to Toronto to learn EVLP techniques from the specialists there. Unlike the handful of hospitals around the world that perform EVLP, Lung Bioengineering does nothing else: Once a set of lungs is delivered, the procedure begins and, if all goes well, the lungs are then placed back on ice for delivery to a surgical team for immediate transplant.

Click here to read more via Bethesda Magazine

GAITHERSBURG, Md., March 18, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into an agreement with Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company, whereby Emergent has agreed to utilize its molecule-to-market contract development and manufacturing (CDMO) services to develop and manufacture Vaxart’s experimental oral vaccine candidate for coronavirus disease (COVID-19). Development services will begin immediately, and upon Vaxart’s election, Emergent agrees to produce clinical material expected to enable Vaxart to initiate a Phase 1 clinical study anticipated early in the second half of 2020. Vaxart’s oral recombinant vaccine candidate is based on its proprietary VAAST™ platform.

“Emergent is pleased to deploy our nimble CDMO expertise to support fellow innovators, like Vaxart, and advance an experimental COVID-19 vaccine candidate,” said Syed T. Husain, senior vice president and CDMO business unit head at Emergent BioSolutions. “We look forward to applying our broad molecule-to-market services, including our ability to work with a multitude of delivery systems, execute under expedited timelines, and meet Vaxart’s potential need for future scalability and large-scale capacity for commercial quantities.”

Under the terms of the agreement, Emergent will provide development services out of its Gaithersburg, Md. location and manufacture drug substance at its Bayview facility in Baltimore, Md., designated a Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services. Emergent’s Bayview CIADM is the same facility used to manufacture drug substance for the company’s recently announced Novavax collaboration. The facility has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis, based upon the platform technology being leveraged. Additionally, it has the unique capability of producing at clinical scale, to get vaccine candidates quickly into the clinic, and in parallel, scaling up to produce commercial volumes to meet customer demand.

“I’m pleased that we are joining forces with an experienced manufacturer such as Emergent to help advance our oral COVID-19 vaccine to the clinic,” said Wouter Latour, MD, chief executive officer of Vaxart. “We believe an oral vaccine administered using a room temperature-stable tablet may offer enormous logistical advantages in the roll-out of a large vaccination campaign, and Emergent is a great partner to help in this endeavor.”

About Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our ability to advance potential solutions to combat coronavirus disease as well as the anticipated production level and use of the COVID-19 experimental vaccine candidate in a Phase 1 clinical study in the expected timeframe, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the success of the planned development program; the timing of and ability to obtain and maintain regulatory approvals for the product candidate; and our commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

Investor Contact:
Robert G. Burrows
Vice President, Investor Relations
240-631-3280
BurrowsR@ebsi.com

Media Contact:
Lynn Kieffer
Vice President, Corporate Communications
240-631-3391
KiefferL@ebsi.com

The BioHealth Capital Region Forum Planning Committee has made the difficult decision to postpone our 6th annual BioHealth Capital Region Forum that was scheduled for April 14th and 15th at AstraZeneca. We believe the health and safety of all participants is of paramount importance. Following the most recent reports from the CDC, the WHO, and the state of Maryland’s ban on gatherings of 250 people or more, we have made this decision.

We are proud of the leadership taken by many of our region’s companies along with federal and state officials in combating the spread of COVID-19.  We want to address both the growing threat of the coronavirus and the state of our region during a Virtual Update on April 14th.

Please stay connected with the BioHealth Capital Region via Twitter, LinkedIn, and Facebook.

We are exploring combining the BioHealth Capital Regional Forum with the BioHealth Capital Regional Investment Conference in October and will advise you of our future direction on these events as soon as we develop our path forward. Thank you for your patience and understanding with this difficult decision. We look forward to e-convening on April 14th.

Cordially,

The BioHealth Capital Region Forum Planning Committee